Variable volume prosthetic assembly

ABSTRACT

A surgically implantable variable volume prosthetic assembly including a first flexible implantable prosthesis having an outer shape approximating that of the human breast, a second flexible container or reservoir having a volume greater than the volume of the first prosthesis with a silicone gel completely filling the reservoir and means for sealingly connecting the reservoir to the prosthesis, the reservoir being squeezed to force the gel into the prosthesis after implantation, the connecting means can be severed and sutured to the back of the prosthesis or a valve can be provided in the connecting means to seal the reservoir and implant during storage and after inflation.

[451 May 20, 1975 VARIABLE VOLUME PROSTHETIC ASSEMBLY [75] Inventor:Henry W. Lynch, Racine, Wis.

[73] Assignee: Medical Engineering Corporation,

Racine, Wis.

22 Filed: Dec. 26, 1973 21 Appl. No.: 428,396

Related U.S. Application Data [63] Continuation-impart of Ser. No.281,150, Aug. 16,

1972, abandoned.

[52] U.S. Cl. 3/36; 3/1; 128/462; l28/D1G. 21 [51] Int. Cl. A61f l/00;A61f l/24; A416 3/10 58 Field ofSearch...3/36, 1,20; 128/462, DIG. 20,128/349 B, 594,595, 230, 232,1)10. 21

[56] References Cited UNITED STATES PATENTS 2,764,759 10/1956 Gazelle128/462 3,044,468 7/1962 Birtwell 128/349 B 3,121,430 2/1964 OReilly128/595 3,416,160 12/1968 Arion 3/36 3,600,718 8/1971 Boone 3/363,663,968 5/1972 Mohl et a1. 3/36 Primary Examiner-Ronald L. FrinksAttorney, Agent, or FirmRonald E. Barry 57 ABSTRACT A surgicallyimplantable variable volume prosthetic assembly including a firstflexible implantable prosthesis having an outer shape approximating thatof the human breast, a second flexible container or reservoir having avolume greater than the volume of the first prosthesis with a siliconegel completely filling the reservoir and means for sealingly connectingthe reservoir to the prosthesis, the reservoir being squeezed to forcethe gel into the prosthesis after implantation, the connecting means canbe severed and sutured to the back of the prosthesis or a valve can beprovided in the connecting means to seal the reservoir and implantduring storage and after inflation.

10 Claims, 8 Drawing Figures PMENTEUHAYZOIHYS 3.883.902

saw 1 or 2 FIG. 2

VARIABLE VOLUME PROSTHETIC ASSEMBLY RELATED APPLICATION This applicationis a continuation-in-part of my copending application entitled VariableVolume Prosthetic Assembly", U.S. Ser. No. 28l,l50, filed Aug. I6, 1972,and now abandoned.

BACKGROUND OF THE INVENTION Implantable prostheses of the type shown inU.S. Pat. No. 3,665,520, entitled Surgically Implantable BreastProsthesis are prefilled to the desired shape with a silicone gel. Inorder to implant a prosthesis in the body, it is necessary to make anincision of a length sufficient to insert the prefilled prosthesisthrough the incision into the body. Once implanted, the volume of thisprosthesis could not be changed without removing the prosthesis. Emptyflexible containers have been implanted in the body and subsequentlyfilled by injecting liquids or a gel into the container. However,difficulties have been encountered in inserting silicone gels into thecontainers having the required viscosity. The equipment required to fillthis type of implant is also more complicated, increasing thedifficultyin maintaining operating room standards.

SUMMARY OF THE INVENTION The variable volume prosthetic assembly of thepresent invention overcomes the above problems by using a closed systemwhich includes a reservoir for storing the gel attached to an emptycontainer. The silicone gel is thus sealed into the closed system at thepoint of manufacture. The entire system can be shipped ready for use andautoclaved at the point of manufacture. The flexible container for theprosthesis can be implanted empty in a rolled up or flattened conditionand therefore can be inserted into a much smaller incision.

Once the empty prosthesis has been implanted, it is a simple step tosqueeze the reservoir to force the silicone gel from the secondcontainer into the prosthesis. The second container is connected to thefirst container by a tube which is secured and sealed to the twoflexible containers. Once the first or implanted container has beenfilled to the desired fullness, the tube can be tied and cut, foldedover and tied, and then sutured to the back of the flexible container.This closed system eliminates the necessity of using additionalequipment to insert the gel into the prosthesis after implanting and asa consequence simplifies the entire operation. The tube can also beprovided with a valve or plug for automatically sealing the containerand reservoir during storage and after implanting the container in thebody.

DRAWINGS FIG. 1 is a plan view of the back of the prosthetic assembly ofthis invention;

FIG. 2 is a side view of the invention showing the tubular connectionbetween the prosthesis and the reservoir;

FIG. 3 is a view of the prosthesis and the reservoir after the gel hasbeen forced into the prosthesis;

FIG. 4 is a partial view of the prosthesis showing the prosthesis afterthe tubular connection has been sealed and folded against the back ofthe prosthesis;

FIG. 5 is a side view of the invention showing a oneway check valve atthe end of the connector tube;

FIG. 6 is an alternate embodiment of the invention wherein a plug orvalve is used to close both the container and reservoir;

FIG. 7 is a view similar to FIG. 6 showing the connecting tube cut offand the valve cut off to seal both the container and the reservoir; and

FIG. 8 is a view of the plug.

DESCRIPTION OF THE INVENTION The implantable prosthetic assembly 10 ofthe present invention as seen in FIG. 1 includes a first flexiblecontainer or shell 12 and a second flexible container or reservoir 14.The containers 12 and 14 are connected by means of a tube 16 which isformed as an integral part of the two containers l2 and 14. The secondeontainer 14 is filled with a silicone gel 18 and the entire assemblyautoclaved at the time of manufacture. The silicone gel 18 istransferred to the implanted shell 12 by squeezing the reservoir 14 toforce the silicone gel 18 into the shell 12.

The first container or shell 12 is formed from an implantable materialsuch as an organopolysiloxane compound as set forth in U.S. Pat. No.3,665,520 or from a silicone rubber such as General Electric ElastomericResin 7000. The G. E. Elastomer resin contains R Si- 0 groups, and smallamounts of vinyl R SiO, where R represents methyl groups. This elastomeris known to have characteristics such as softness and resiliency'thatcan be controlled to approximate that of the human body. The container12 can be made to approximate any shape and as shown is formed with afront surface 11 having the general shape of a natural breast and a backsurface 22 which is shapedto follow the general contour of the chestwall.

The second container or reservoir 14 can be formed from the samematerial as the first container 12 or from a medical grade material suchas silicone polycarbonate copolymer. The reservoir 14 preferably has avolume equal to or greater than the volume of the first container 12. Ifdesired, graduations 24 can be provided on the surface of the reservoir14 to indicate the amount of silicone gel 18 available to be forced intothe prosthesis 12.

The second container 14 is filled with the silicone gel 18 such as setforth in US. Pat. No. 3,665,520. As an example, a gel containing a majorcomponent of R SiO, a minor component of vinyl R SiO and small amountsof R.vinyl R SiO and R SiO has been used successfully. Other gelsapproved for medical use can be used if desired.

The reservoir 14 and shell 12 can be rotationally cast on a mold of therequired shape. The mold is dipped in the liquid elastomer and rotatedto form the reservoir or container on the outside of the mold. The moldis re peatedly dipped and rotated to cure the elastomer until theassembly has the desired wall thickness. The wall of the containers 12and 14 formed of this material has little if any rigidity and is verysoft and flexible in com-- pression but is known to have a tensilestrength satisfactory for this use.

The two containers 12 and 14 are interconnected by means of a tube 16.In this regard, the tube 16 is provided at one end with a flange 17which is connected to the inside of the container 12. The other end ofthe tube 16 is bonded to an opening 15 provided in the reservoir 14.Thetube 16 can be reinforced with a fabric 19 such as Dacron or nylon ifdesired.

The shell 12 is implanted by inserting the shell 12 through a smallincision in the patient. The shell can be rolled up and inserted as atube and the unrolled after implanted or inserted flat, whichever ispreferred. The second container or reservoir 14 as seen in FIG. 3 isthen squeezed or rolled to force the gel 18 from the reservoir 14through the tube 16 into the shell 12 to fill the prosthesis. The amountof silicone gel 18 forced into the prosthesis can be determined byobserving the graduations 24 provided on the wall of the reservoir 14and also observing the extent of expansion of the body. After theprosthesis 12 has been filled to the desired size, the tube 16 is tiedoff with a surgical thread 26. The tube is then cut at 28 to remove thereservoir. The remaining portion of the tube is then folded at the tiethread 26 and sutured or tied by means of a thread 27 to hold the tubein place on the back 22 of the prosthesis 12 as seen in FIG. 4. Itshould be noted that during this entire procedure, the silicone gel 18is sealed in the reservoir and is never exposed to the atmosphere andwill remain sterile during the entire operation.

Referring to FIG. 5, means are shown for preventing back flow of gelfrom the first container 12 to the second container or reservoir 14.Such means is in the form of a'one-way valve 30 provided at the end ofthe tube 16 and within the first container 12. The one-way valve shownis a duck bill type valve having upper and lower resilient flaps 32 and34 extending into the container 12. The valve 30 allows for theadmission of gel into the container 12 but will prevent back flow of gelfrom the container 12.

Referring to FIGS. 6 and 7, an alternate embodiment of the invention isshown which includes means for sealing the container 12 from thereservoir 14 and for closing both the container and reservoir afterimplant.

- In this embodiment, a resilient tube 40 made of medical grade materialis shown having one end 42 sealed to the reservoir 14 by means of atransverse tube 45 and the flange 46 when the head 56 is seated in thesection 48. The slot 60 is used as a guide to determine the location ofthe point-of cut-off of the tube and to simplify cutting the plug byproviding the reduced diameter cutoff section 59.

in regard to this last, after the implant 12 has been filled with thegel, the plug 52 is moved from the section 54 through the tube 40 bysqueezing the section 54 and tube 40 behind the plug 12. The gel acts asa lubricant and allows the plug 52 to slide freely into the section 48.The head 56 of the plug 52 will fit snugly within section 48 blockingthe flow of gel from the reservoir. The tube 40 and reduced section 59are then cut at the slot 60. The section 57 remaining in the tube 40will act as a plug preventing any gel in the tube 40 from flowing out ofthe tube 40 after the reservoir 14 has been removed.

RESUME The variable volume prosthetic assembly of this inventionprovides a simple sterile method for implanting a prosthesis. Oncefilled, the reservoir and container can be stored and shipped withoutany fear of contamination. The incorporation ofa self-sealing valve orplug into the tube eliminates the possibility of any gel escaping fromthe implant. After the container or shell has been implanted, the shellcan be filled to the extent required to fill out the portion of theanatomy to be augmented. Although prostheses of the type disclosedherein are more commonly used as a breast prosthesis, the prosthesis orcontainer can also be used in other parts of the body either as areplacement or augmentation prosthesis.

I claim:

1. A closed system variable volume prosthetic assembly comprising:

other end 44 sealed directly to the opening 47 in the container 12. Inthis regard, the end 44 is provided with a flange 46 which extendsradially outwardly from the tube 40 and is sealed by means of a suitableadhesive to the wall of the conainer 12. An enlarged diameter section 48is provided within the container 12 at the end 44 of the tube 40. Theenlarged diameter section 48 includes an opening 50 at the inner end toallow for the flow of gel through the section 48 into the container. Theother end of the tube 40 is closed by means of enlarged section 54.

The tube 40 is closed or blocked by means of a plug 32 which is normallylocated in tube 40 to prevent gel from flowing in the container 12during storage. The plug 56 is moved into the closed enlarged section 54formed on the end 42 of the tube 40 after the container 12 has beenimplanted to allow for the flow of gel from the reservoir into thecontainer.

The plug 52 includes a head 56 having an outer diameter substantiallyequal to the inner diameter of the section 48, body 58 having a diametersubstantially equal to the diameter of the tube 40 and an enlargedmember 57 having a diameter substantially equal to the diameter of thehead 56. A slot or groove is provided in the body 58 to form a reduceddiameter cut-off section 59 between the body 58 and member 57. The body58 should have a length long enough to extend beyond a first flexiblecontainer adapted to be implanted in the body,

a second flexible container having a volume greater than the volume ofsaid first container,

a silicone gel completely filling said second container,

a tube sealingly connecting said second container to said firstcontainer whereby said gel can be squeezed from said second containerinto said first container after implantation of said first container andsaid assembly can be autoclaved prior to implant without contaminatingthe gel,

and valve means within said tube for movement to a position closing thetube after the gel has been forced into said container.

2. The assembly according to claim 1 wherein said valve means comprisesan enlarged section connected to one end of said tube and a plugpositioned in said enlarged section and being movable into said tube forblocking the tube.

3. A closed variable volume prosthetic assembly comprising:

a shell having the shape of a part of the body to be replaced, areservoir having a volume at least equal to the volume of saidcontainer, a medical grade gel filling said reservoir, tube meansconnecting said reservoir to said shell to form a closed completelysealed container for transporting and storing said gel,

and valve means in said tube means for closing said tube means after thegel has been forced into said shell whereby said assembly can beautoclaved prior to use and said reservoir can be squeezed to force thegel from said reservoir into said shell after the implantation.

4. The assembly according to claim 3 wherein said valve means includes aplug in said tube means, said plug having a head for closing saidcontainer after implant and an enlarged member for closing said tubeafter removal from said container.

5. The assembly according to claim 4 wherein said plug includes areduced diameter section between said head and enlarged member toindicate the cut off line for said tube.

6. A sealed variable volume prosthetic assembly comprising:

a flexible container adapted to be implanted. in the body,

a flexible reservoir having a volume greater than the volume of saidcontainer,

a medical grade gel filling said reservoir,

tube means for sealing said reservoir to said container whereby said gelcan be squeezed from said reservoir into said container afterimplantation of said container in the body,

and plug means in said tube means for closing said container and saidreservoir after separating the reservoir from the container.

7. The assembly according to claim 6 wherein said tube means includes afirst tube having one end sealed to said container and a second tubehaving one end connected to said reservoir and the other end to saidfirst tube so that said plug means can be moved through said first tubeto close said container.

8. The assembly according to claim 7 wherein said closing meanscomprises a plug having a head for sealing the container and a secondportion for sealing the tube.

9. The assembly according to claim 7 wherein said first tube includes anopen enlarged diameter section at said one end disposed within saidcontainer and a closed enlarged diameter section at the said other end,and said plug means is disposed in said tube for movement into saidclosed section, said plug means being movable through said tube into theopen section in the container.

10. The assembly according to claim 9 wherein said plug means includes ahead for closing the open section and an enlarged diameter member forclosing said tube. l

1. A closed system variable volume prosthetic assembly comprising: afirst flexible container adapted to be implanted in the body, a secondflexible container having a volume greater than the volume of said firstcontainer, a silicone gel completely filling said second container, atube sealingly connecting said second container to said first containerwhereby said gel can be squeezed from said second container into saidfirst container after implantation of said first container and saidassembly can be autoclaved prior to implant without contaminating thegel, and valve means within said tube for movement to a position closingthe tube after the gel has been forced into said container.
 2. Theassembly according to claim 1 wherein said valve means comprises anenlarged section connected to one end of said tube and a plug positionedin said enlarged section and being movable into said tube for blockingthe tube.
 3. A closed variable volume prosthetic assembly comprising: ashell having the shape of a part of the body to be replaced, a reservoirhaving a volume at least equal to the volume of said container, amedical grade gel filling said reservoir, tube means connecting saidreservoir to said shell to form a closed completely sealed container fortransporting and storing said gel, and valve means in said tube meansfor closing said tube means after the gel has been forced into saidshell whereby said assembly can be autoclaved prior to use and saidreservoir can be squeezed to force the gel from said reservoir into saidshell after the implantation.
 4. The assembly according to claim 3wherein said valve means includes a plug in said tube means, said plughaving a head for closing said container after implant and an enlargedmember for closing said tube after removal from said container.
 5. Theassembly according to claim 4 wherein said plug includes a reduceddiameter section between said head and enlarged member to indicate thecut off line for said tube.
 6. A sealed variable volume prostheticassembly comprising: a flexible container adapted to be implanted in thebody, a flexible reservoir having a volume greater than the volume ofsaid container, a medical grade gel filling said reservoir, tube meansfor sealing said reservoir to said container whereby said gel can besqueezed from said reservoir into said container after implantation ofsaid container in the body, and plug means in said tube means forclosing said container and said reservoir after separating the reservoirfrom the container.
 7. The assembly according to claim 6 wherein saidtube means includes a first tube having one end sealed to said containerand a second tube having one end connected to said reservoir and theother end to said first tube so that said plug means can be movedthrough said first tube to close said container.
 8. The assemblyaccordiNg to claim 7 wherein said closing means comprises a plug havinga head for sealing the container and a second portion for sealing thetube.
 9. The assembly according to claim 7 wherein said first tubeincludes an open enlarged diameter section at said one end disposedwithin said container and a closed enlarged diameter section at the saidother end, and said plug means is disposed in said tube for movementinto said closed section, said plug means being movable through saidtube into the open section in the container.
 10. The assembly accordingto claim 9 wherein said plug means includes a head for closing the opensection and an enlarged diameter member for closing said tube.